Ülke: Endonezya
Dil: Endonezce
Kaynak: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LENVATINIB MESILATE
EISAI INDONESIA - Indonesia
LENVATINIB MESILATE
4 MG
KAPSUL
DUS, 2 BLISTER @ 10 KAPSUL
PATHEON SA - Canada
2018-07-17
PT Eisai Indonesia | Product Information LENVIMA 1 1. NAME OF THE MEDICINAL PRODUCT LENVIMA 4 mg hard capsules LENVIMA 10 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION LENVIMA 4 mg hard capsules Each hard capsule contains 4 mg of lenvatinib (as mesilate). LENVIMA 10 mg hard capsules Each hard capsule contains 10 mg of lenvatinib (as mesilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. LENVIMA 4 mg hard capsules A yellowish-red body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 4 mg” on the body. LENVIMA 10 mg hard capsules A yellow body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 10 mg” on the body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LENVIMA is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). LENVIMA is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION LENVIMA treatment should be initiated and supervised by a health care professional experienced in the use of anticancer therapies. If a patient misses a dose, and it cannot be taken within 12 hours, then that dose should be skipped and the next dose should be taken at the usual time of administration. Disetujui oleh Badan POM: 12/11/2019 EREG17180811900025 EREG17180811900026 PT Eisai Indonesia | Product Information LENVIMA 2 Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs. Optimal medical management (i.e. treatment or therapy) for nausea, vomiting, and diarrhoea should be initiated prior to any lenvatinib therapy interruption or dose reduction; gastrointestinal Belgenin tamamını okuyun